Archives for June 2015

Pharmacy Response to King v. Burwell Decision

For many pharmacy organizations, the Supreme Court King v. Burwell decision upholding the Affordable Care Act’s (ACA) tax subsidies fended off potential confusion for patients concerning health insurance.
 
National Community Pharmacists Association CEO B. Douglas Hoey, RPh, MBA, remarked that community pharmacists are often the first providers that Americans—especially those who are in underserved rural and inner-city areas—turn to for help. Community pharmacists can assist those with and without insurance in obtaining the medications they need, Hoey said.
 
“While the political debate over US health care will continue, (this) ruling provides a degree of clarity for community pharmacists, as they continue to help patients navigate a complicated health care system,” he stated.
 
Likewise, the National Association of Chain Drug Stores (NACDS) noted that pharmacists can play a role in improving patients’ health insurance comprehension.
 
“Pharmacy remains committed to helping patients understand their coverage, which has been a priority throughout the roll-out of exchange-based insurance, as well as to maximizing the valuable role of pharmacies in today’s evolving health care delivery models,” the NACDS wrote.
 
The NACDS also called for pharmacy Medicaid provisions of the ACA to be implemented, allowing for more access to pharmacist-provided patient care.
 
Academy of Managed Care Pharmacy CEO Edith A. Rosato, RPh, IOM, praised the King v. Burwell decision, referencing a Kaiser Family Foundation estimate that 6.4 million individuals would have lost subsidies worth $1.7 billion per month if the court had ruled in favor of the plaintiffs. In addition, premiums for subsidized enrollees could have seen massive increases. 
 
“Whatever one’s view of the ACA, there’s no denying that this decision has averted significant disruption to the health care marketplace,” Rosato wrote.
 
While the American Society of Consultant Pharmacists (ASCP) does not foresee any changes to the consultant pharmacy profession and long-term care industry as a result of the ruling, it did recognize that the decision adds more certainty to the future of the nation’s health insurance system.

“[T]he decision allows our members to continue efforts to work with other professions in the health care arena to deliver higher quality, more cost-effective care to the nation’s seniors,” the ASCP said in a statement.

International Academy of Compounding Pharmacists executive vice president and CEO David G. Miller, RPh, said he also does not expect any changes for the compounding community as a result of the King v. Burwell decision. 
 
“Although prescription drugs are a component of both federal and state exchanges, the coverage policy for compounds varies,” he said in a statement. “We do not anticipate today’s Supreme Court ruling to impact that.”
 
Both Generic Pharmaceutical Association (GPhA) president and CEO Ralph Neas, JD, and International Pharmaceutical Federation (FIP) CEO Luc Besançon expressed positive outlooks from the ruling.
 
“With today’s decision, GPhA and its members look forward to working with policymakers to ensure that timely access to safe, effective, and more affordable generic drugs and biosimilars continues for millions of people,” Neas told Pharmacy Times.
 
“The ACA is in line with the concept of universal health coverage, which the FIP—pharmacists and pharmaceutical sciences around the world—strongly supports,” Besançon said. “Any policy or reform that helps to ensure access to quality-assured health products and services for all is to be encouraged.”
 
Many had feared there would be chaos in the insurance marketplace if the court had sided with the plaintiffs.
 
For instance, Justice Sonia Sotomayor had previously suggested that if the court shot down tax subsidies, a “death spiral” would result. Without a requirement to sign up, only the sickest would enroll for health insurance, causing premiums to skyrocket and more individuals to drop out of health insurance.
 
However, the ruling will allow ACA tax credits for those who signed up for insurance using state or federal exchanges. 

Tricare: Compounded medication orders fall sharply

A change to Tricare’s compounded medication coverage policy May 1 slashed costs for these medications by more than 74 percent in less than a month.

But for some patients, the switch has been anything but easy.

Three More Compounders Hit With Sterility Issue Warnings

The FDA has warned three more drug compounding pharmacies over sterility issues and other GMP shortcomings, bringing to 12 the number cited since October.

Florida-based Premier Pharmacy Labs and HHCS Pharmacy and Noblesville, Ind.-based Pharmakon Pharmaceuticals were cited for failing to maintain sterile rooms for manufacturing and failing to establish and follow procedures for preventing contamination.

Clinical Perspectives in Compounding

Human Factors in Sterile Compounding Involving a Hospital Pharmacy

Docs Fight for Right to Compound Drugs

Following the 2012 scandal involving 64 patients who died and another 750 who became ill with fungal meningitis traced to unsterile conditions in a New England compounding pharmacy, the US Food and Drug Administration has been given new powers to enforce safety issues related to that practice.But at the American Medical Association’s annual House of Delegates (HOD) meeting in Chicago June 7, physicians from several medical specialties urged the AMA to lobby for regulations safe-guarding their own right to compound drugs in their offices.Those who spoke included dermatologists, ophthalmologists, infectious disease doctors, and oncologists.

FDA Committee to Continue Considering Drug Compounding Issues

The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access to investigational new drugs and what components can be used in compounded products, among other topics.

Automated Compounding Enhances Safety and Regulatory Compliance

Several recent events point to glaring problems in ensuring the safety of compounded sterile preparations (CSPs)—problems that technology might be able to solve.

In January, the Department of Health and Human Services’ Office of Inspector General (OIG) issued a report about hospitals’ use of stand-alone compounding pharmacies for CSPs. The study was spurred by concerns about the quality of CSPs after the 2012 meningitis outbreak and deaths caused by contaminated injections from the New England Compounding Center (NECC), an independent compounding pharmacy.

According to the OIG, most acute care hospitals use CSPs and get at least some of them from stand-alone compounding pharmacies. For hospitals that participate in Medicare, the Centers for Medicare & Medicaid Services (CMS) and other agencies are responsible for overseeing the safety of CSPs as part of the hospital certification process. However, the OIG found, most CMS oversight agencies do not consistently review hospitals’ preparation and use of CSPs, nor their contracts with the pharmacies that supply them.
Although the report did not speculate whether such inconsistencies could put patients at risk, the OIG recommended that CMS inspectors receive more training on safe compounding standards and regularly review hospital contracts with compounding pharmacies.
Clearly, the NECC meningitis outbreak continues to resonate among health care providers and policymakers. The Drug Quality and Security Act (DQSA), passed by the U.S. Congress in 2013 in response to the NECC tragedy, provides enhanced rules for preparing and tracking compounded medications. The law allows compounding pharmacies to voluntarily register with FDA as outsourcing facilities (hospitals that participate in Medicare are required to purchase CSPs only from registered outsourcing facilities) and undergo enhanced inspections.
Although DQSA was a step in the right direction, it still does not resolve several critical issues. Chain of custody documentation and inspections that are more stringent are improvements, but neither addresses the biggest risk to the safety of CSPs: manual compounding.
The fact is manual compounding is fraught with risks from human error and contamination. Instituting extra process steps, including checks and rechecks, may be reasonable, but each extra step adds another opportunity for errors to be made. Putting aside the mold-covered equipment that inspectors found at NECC, just misreading the label on an admixture vial could be hazardous.
In 2007, actor Dennis Quaid’s twin infants received adult doses of a blood thinner–1,000 times stronger than a pediatric dose–because a pharmacy technician drew medication from a vial whose label was similar to the vial that should have been used (both infants survived). Last December, a woman in Oregon died after receiving an IV containing the wrong medication during an emergency department visit, although the label on the bag listed the medication that was ordered by her physician. Inspections that are more frequent may not have prevented either of these errors, but automated compounding could have done so.
From a regulatory standpoint, automated compounding provides many advantages. Some systems already have features that would allow compliance with DQSA; for example, an electronic audit trail documenting the details of every dose dispensed, including every vial used, an aseptic compounding chamber with ISO Class 5 air and much more. Some systems are also fully compliant with USP Chapter <797> compounding standards, also required by DQSA.
As the population ages and more people rely both on hospitals and compounded medications provided by their doctors (such as in the NECC case), ensuring the safety of CSPs is going to be even more important. If Congress and the FDA really want to ensure the safety of compounded drugs, as well as assure that compounding pharmacies comply with regulations, then they must provide incentives for outsourcing pharmacies (and, for that matter, hospital pharmacies) to implement automated compounding.